- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635466
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma (Lap RC)
June 15, 2011 updated by: Japan Society of Laparoscopic Colorectal Surgery
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure.
In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier.
To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.
Study Type
Interventional
Enrollment (Actual)
495
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kanagawa
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Sagamihara, Kanagawa, Japan, 228-8555
- Kitasato University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically proven rectal carcinoma.
- Tumor located in the rectum.
- Clinical Tis, T1, T2 N0 M0
- Without multiple lesions other than carcinoma in situ
- Tumor size <8 cm.
- Sufficient organ function.
- No bowel obstruction.
- No history of major colorectal surgery.
- No history of chemotherapy or radiotherapy.
- Provide written informed consent.
Exclusion Criteria:
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- Pregnant or lactating women.
- Severe mental disease.
- Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
- Continuous systemic steroid therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lap, 1
Patients undergoing laparoscopic surgery for rectal carcinoma
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Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum.
The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge.
Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle.
Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5 year
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5 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
anastomotic leakage rate
Time Frame: 1 month
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Masahiko Watanabe, PhD, Kitasato University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26.
- Ito M, Yamamoto S, Okuda J, Fujii S, Yamaguchi S, Otsuka K, Yoshimura K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma. Ann Gastroenterol Surg. 2020 May 20;4(3):294-300. doi: 10.1002/ags3.12333. eCollection 2020 May.
- Yamamoto S, Ito M, Okuda J, Fujii S, Yamaguchi S, Yoshimura K, Sugihara K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial. Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
March 6, 2008
First Submitted That Met QC Criteria
March 12, 2008
First Posted (Estimate)
March 13, 2008
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lap RC
- NCCHCT19-49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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